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. 2025 Jun 23:80:100716.
doi: 10.1016/j.clinsp.2025.100716. Online ahead of print.

A randomized controlled trial comparing the efficacy and safety of indobufen versus aspirin in reducing target vessel restenosis after drug-eluting balloon angioplasty in patients with coronary artery disease

Zhenhua Jiang  1 , Dewen Zhu  1 , Jiangqian Meng  2
Affiliations

A randomized controlled trial comparing the efficacy and safety of indobufen versus aspirin in reducing target vessel restenosis after drug-eluting balloon angioplasty in patients with coronary artery disease

Zhenhua Jiang et al. Clinics (Sao Paulo). .

Abstract

Objective: This randomized controlled trial aimed to compare the efficacy and safety of indobufen versus aspirin in reducing Target Vessel Restenosis (TVR) after Drug-Eluting Balloon (DEB) angioplasty in patients with Coronary Artery Disease (CAD).

Background: Despite advancements in Percutaneous Coronary Intervention (PCI) techniques, TVR remains a significant challenge. Antiplatelet therapy is crucial in managing patients post-PCI, and while aspirin is the standard, indobufen may offer a more favorable safety profile by reducing gastrointestinal adverse reactions.

Methods: The authors conducted a prospective, single-blind, randomized controlled trial involving patients with CAD undergoing PCI with DEB. Patients were randomly allocated to receive either indobufen 100 mg twice daily or aspirin 100 mg daily, both in conjunction with clopidogrel 75 mg daily, for at least 12-months post-procedure. The primary endpoint was TVR assessed by quantitative coronary angiography at 12-months, while secondary endpoints included Major Adverse Cardiovascular Events (MACE), bleeding complications, and patient-reported outcomes.

Results: A total of 240 patients were evenly distributed between the indobufen and aspirin groups. No significant differences were observed in the rates of TVR (5.83 % vs. 7.50 %, p = 0.603) and MACE (5.00 % vs. 5.83 %, p = 0.776) between the two groups at one-year post-procedure. Importantly, no significant difference in gastrointestinal bleeding rates was observed between the indobufen and aspirin groups (p = 0.156).

Conclusion: Indobufen demonstrated non-inferior efficacy to aspirin in preventing TVR and MACE after DEB angioplasty in patients with CAD, with comparable safety profiles and no significant difference in gastrointestinal bleeding rates. However, indobufen is relatively more expensive than aspirin. While the present results suggest that indobufen may be a viable alternative to aspirin, particularly in patients at higher risk of gastrointestinal adverse reactions, this conclusion should be interpreted with caution due to the study's limitations, including its single-blind design and relatively small sample size.

Keywords: Angioplasty; Antiplatelet Therapy; Aspirin; Drug-eluting balloon (DEB); Indobufen; Target vessel restenosis (TVR).

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig. 1
Kaplan-Meier estimate of MACE-free survival rate for indobufen and aspirin groups over 12-months.
See this image and copyright information in PMC

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